Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL

NCT06635330 | Recruiting Phase 1 DMC

• 1 other identifier: IR.NREC.1403.003
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the safety and efficacy of CD19 CAR-T cells in pediatric patients of all genders, aged 2 to 18 years, with relapsing or refractory B cell acute lymphoblastic leukemia (r/r B-ALL). The main questions it aims to answer are as following:

1. 1.What is the percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi)?
2. 2.What is the rate of Event-free survival at first month and 2-3 months after intervention?
3. 3.What is the rate of Overall survival at first month and at 3 months after the intervention?

Conditions

Relapse/Refractory B-cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (5)

• Percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi)

  First month and 2-3 months after intervention

• Overall survival

  First month and 3 months after intervention

• Incidence of cytokine release syndrome: grade 3 and 4

  First month and 3 months after intervention

• Incidence of Immune effector cell-associated neurotoxicity syndrome (ICANS): grade 3 and 4

  First month and 3 months after intervention

• Event-free survival

  First month and 2-3 months after intervention

Secondary Outcomes (9)

• Percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi)

  6 months and 12 months after intervention

• Investigation of Minimal residual disease in patient

  First month and 2-3 months after intervention

• Incidence of cytokine release syndrome: grade 3 and 4

  6 months and 12 months after intervention

• Incidence of Immune effector cell-associated neurotoxicity syndrome (ICANS): grade 3 and 4

  6 months and 12 months after intervention

• Incidence of tumor lysis syndrome (TLS)

  Months 1, 3, 6, and 12 after the intervention

Study Arms (1)

Anti-CD19 CAR-T treatment group

EXPERIMENTAL

Biological: anti-CD19 CAR T cell therapy

Interventions

anti-CD19 CAR T cell therapy BIOLOGICAL

Anti-CD19 CAR-T cell therapy for R/R B-ALL pediatric patients. For patients 50 kg and less: 0.2 to 5 in ten to the power of six live CAR+ T cells per kilogram of body weight/ For patients over 50 kg: 0.1 to 2.5 in ten to the power of eight live CAR+ T cells (without considering weight).

Anti-CD19 CAR-T treatment group

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 2 to 18 years with relapsed or refractory CD19+ B-ALL
• Presence of disease in the bone marrow
• Able to tolerate the apheresis process
• Life expectancy \> 12 weeks
• Lansky or Karnofsky score \> 50%
• At least 7 days passed since the last chemotherapy and the last treatment with corticosteroids
• Informed consent
• Having potential donor for stem cell transplantation

You may not qualify if:

• Presence of active malignancy other than the disease under study
• Chloroma and leukemic infiltration on MRI or significant neurological symptoms
• Any CNS disorder
• Presence of active GVHD
• Radiation therapy within last 14 days
• History of Anti-CD19 or Anti-CD20 therapy
• Donor lymphocyte injection or other cell therapy methods within the last 30 days
• Presence of severe active infection
• Organ dysfunction

Sponsors & Collaborators

• Kara Yakhteh Tajhiz Azma Company: lead

Study Sites (1)

Pediatric cell and gene therapy research center, Children medical center

Tehran, Tehran Province, 1419733151, Iran

RECRUITING

MeSH Terms

Conditions

Recurrence; Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Setayesh Sadeghi

CONTACT

+989124779968; sadeghi.setayesh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 10, 2024
• Study Start: May 20, 2024
• Primary Completion (Estimated): September 22, 2026
• Study Completion (Estimated): September 22, 2027
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

IR (1)